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Found 3 results
510(k) Data Aggregation
K Number
K011329Device Name
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
Manufacturer
E. BENSON HOOD LAB, INC.
Date Cleared
2002-07-26
(451 days)
Product Code
BXQ
Regulation Number
868.1800Why did this record match?
Applicant Name (Manufacturer) :
E. BENSON HOOD LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000154Device Name
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
Manufacturer
E. BENSON HOOD LAB, INC.
Date Cleared
2000-03-29
(70 days)
Product Code
FWN
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
E. BENSON HOOD LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974132Device Name
VOICE MASTER PROSTHESIS
Manufacturer
E. BENSON HOOD LAB, INC.
Date Cleared
1998-02-25
(114 days)
Product Code
EWL
Regulation Number
874.3730Why did this record match?
Applicant Name (Manufacturer) :
E. BENSON HOOD LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.
Device Description
This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.
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